Medical Writing Services
A contract research organization
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Medical writing services

Our medical writing expertise has played a key role in obtaining many health authority approvals of global and country-specific submission dossiers for new medicines and line extensions.  Our track record for quality and successful outcomes for our clients is the direct result of more than 30 years of experience in the industry, combined with integrity and flexibility.
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Consistently high standards and on-time project completion are maintained by focusing on the following mission-critical documents:
  • Study protocols (Phase I-IV)
  • Investigator brochures
  • Clinical study reports
  • Clinical summary documents for global submission dossiers (CTD format)
  • Patient safety narratives
  • Health authority briefing documents
  • Submission-related responses to health authority questions
  • Responses to pre- and post-approval health authority requests
  • Periodic safety reports.
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